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Guide to Microbiology Laboratories in the Pharmaceutical Industry VERSION 3 will be available from September 2025
The concept of the Guide to Microbiology Laboratories in the Pharmaceutical Industry was first conceived several years ago by Dr Kerry Hawitt and Dr Tim Sandle who started writing this document as a pocket guide to microbiology laboratories.
Then in 2011 a revised guide was published, with significant additions from Julie Roberts.
This 3rd edition was further revised and edited by David Keen. The document serves to compile and distil down in one place, all the various guidance that already exist on how best to run a microbiology laboratory. The result is this guide, which details what Pharmig considers to be best practices for a microbiology laboratory based in the pharmaceutical industry.
Chapters covered in this 3rd edition include:
- Relationship to the quality unit
- Training
- Microbiology facility design for testing of pharmaceutical products
- Qualification and maintenance of laboratory equipment
- Cleaning & disinfection of the laboratory and equipment
- Laboratory consumables
- Culture media
- Microorganisms
- Method verification and suitability
- Microbiological testing for starting materials, intermediates & finished product
- Microbiological test methods
- Rapid microbiological methods (RMMs) & moderns microbiological methods
- Environmental monitoring
- Interpretation of assay results (out of specification, EM excursions, out of trend handling)
- Documentation and laboratory records
- References
To preorder – please send your request to maxine@pharmig.org.uk
If the publication is available earlier than September – you will be notified.
